Hand Sanitizer
- Product NDC
- 58418-116
- 11-digit product format
- 584180116
- Labeler code
- 58418
- Product ID
- 58418-116_9da604db-9825-b2bc-e053-2a95a90a9646
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hand Sanitizer
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Tropical Enterprises International, Inc.
- Application
- part333E
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2012-08-01
- Marketing end
- 0000-00-00
- Substance
- ALCOHOL
- Active strength
- 20 mL/30mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 58418-116 | D | Discontinued by firm | 2026-10-12 | ||
| excluded product | product | 58418-116 | I | Inactivated by FDA | 2026-10-12 | ||
| excluded package | package | 58418-116 | 58418-116-00 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-01 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-02 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-04 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-05 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-08 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-10 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-12 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-16 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-28 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-64 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-00 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-01 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-02 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-04 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-05 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-08 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-09 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-10 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-12 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-15 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-16 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-18 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-25 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-28 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-32 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-55 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-64 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-70 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 58418-116 | 58418-116-99 | I | Inactivated by FDA | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-00 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-15 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-12 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-02 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-01 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-10 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-28 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-12 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-70 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-25 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-04 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-32 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-01 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-00 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-02 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-10 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-18 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-64 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-55 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-99 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-04 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-08 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-09 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-16 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-28 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-08 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-64 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58418-116-16 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-00 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-15 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-12 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-02 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-05 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-10 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-28 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-12 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-70 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-25 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-04 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-32 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-01 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-00 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-02 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-10 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-18 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-64 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-55 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-99 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-04 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-08 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-09 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-05 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58418-116-16 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58418-116-00 | Hand Sanitizer | 10 mL in 1 PACKET | GEL | 10 | 5 | |
| 58418-116-01 | Hand Sanitizer | 30 mL in 1 BOTTLE, PLASTIC | GEL | 30 | 5 | |
| 58418-116-02 | Hand Sanitizer | 60 mL in 1 BOTTLE, PLASTIC | GEL | 60 | 5 | |
| 58418-116-04 | Hand Sanitizer | 120 mL in 1 BOTTLE, PLASTIC | GEL | 120 | 5 | |
| 58418-116-05 | Hand Sanitizer | 15 mL in 1 BOTTLE, PLASTIC | GEL | 15 | 5 | |
| 58418-116-08 | Hand Sanitizer | 240 mL in 1 BOTTLE, PUMP | GEL | 240 | 5 | |
| 58418-116-09 | Hand Sanitizer | 240 mL in 1 BOTTLE, DISPENSING | GEL | 240 | 5 | |
| 58418-116-10 | Hand Sanitizer | 10 mL in 1 BOTTLE, SPRAY | GEL | 10 | 5 | |
| 58418-116-12 | Hand Sanitizer | 360 mL in 1 BOTTLE, PUMP | GEL | 360 | 5 | |
| 58418-116-15 | Hand Sanitizer | 45 mL in 1 BOTTLE, DISPENSING | GEL | 45 | 5 | |
| 58418-116-16 | Hand Sanitizer | 480 mL in 1 BOTTLE, PUMP | GEL | 480 | 5 | |
| 58418-116-18 | Hand Sanitizer | 52 mL in 1 BOTTLE, DISPENSING | GEL | 52 | 5 | |
| 58418-116-25 | Hand Sanitizer | 960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | GEL | 960000 | 5 | |
| 58418-116-28 | Hand Sanitizer | 840 mL in 1 BOTTLE, PUMP | GEL | 840 | 5 | |
| 58418-116-32 | Hand Sanitizer | 1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | GEL | 1228800 | 5 | |
| 58418-116-55 | Hand Sanitizer | 30 mL in 1 BOTTLE, DISPENSING | GEL | 30 | 5 | |
| 58418-116-64 | Hand Sanitizer | 1920 mL in 1 BOTTLE, PUMP | GEL | 1920 | 5 | |
| 58418-116-70 | Hand Sanitizer | 211200 mL in 1 DRUM | GEL | 211200 | 5 | |
| 58418-116-99 | Hand Sanitizer | 3840 mL in 1 JUG | GEL | 3840 | 5 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58418-116-00 | 58418011600 | 10 mL in 1 PACKET (58418-116-00) | 10 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-01 | 58418011601 | 30 mL in 1 BOTTLE, PLASTIC (58418-116-01) | 30 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-02 | 58418011602 | 60 mL in 1 BOTTLE, PLASTIC (58418-116-02) | 60 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-04 | 58418011604 | 120 mL in 1 BOTTLE, PLASTIC (58418-116-04) | 120 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-05 | 58418011605 | 15 mL in 1 BOTTLE, PLASTIC (58418-116-05) | 15 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-08 | 58418011608 | 240 mL in 1 BOTTLE, PUMP (58418-116-08) | 240 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-09 | 58418011609 | 240 mL in 1 BOTTLE, DISPENSING (58418-116-09) | 240 ml | 2017-01-02 | 0000-00-00 | No | No | Current |
| 58418-116-10 | 58418011610 | 10 mL in 1 BOTTLE, SPRAY (58418-116-10) | 10 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-12 | 58418011612 | 360 mL in 1 BOTTLE, PUMP (58418-116-12) | 360 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-15 | 58418011615 | 45 mL in 1 BOTTLE, DISPENSING (58418-116-15) | 45 ml | 2020-02-02 | 0000-00-00 | No | No | Current |
| 58418-116-16 | 58418011616 | 480 mL in 1 BOTTLE, PUMP (58418-116-16) | 480 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-18 | 58418011618 | 52 mL in 1 BOTTLE, DISPENSING (58418-116-18) | 52 ml | 2020-02-02 | 0000-00-00 | No | No | Current |
| 58418-116-25 | 58418011625 | 960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (58418-116-25) | 960000 ml | 2020-04-01 | 0000-00-00 | No | No | Current |
| 58418-116-28 | 58418011628 | 840 mL in 1 BOTTLE, PUMP (58418-116-28) | 840 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-32 | 58418011632 | 1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (58418-116-32) | 1228800 ml | 2020-02-02 | 0000-00-00 | No | No | Current |
| 58418-116-55 | 58418011655 | 30 mL in 1 BOTTLE, DISPENSING (58418-116-55) | 30 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-64 | 58418011664 | 1920 mL in 1 BOTTLE, PUMP (58418-116-64) | 1920 ml | 2012-08-01 | 0000-00-00 | No | No | Current |
| 58418-116-70 | 58418011670 | 211200 mL in 1 DRUM (58418-116-70) | 211200 ml | 2020-02-02 | 0000-00-00 | No | No | Current |
| 58418-116-99 | 58418011699 | 3840 mL in 1 JUG (58418-116-99) | 3840 ml | 2020-02-02 | 0000-00-00 | No | No | Current |